MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	3708660
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot#: va257lh, implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient's extension and lead were damaged.Stage 1 and stage 2 were performed on the same day.When attempting to tighten the screw on the extension/lead connection, one screw would not torque.When attempting to troubleshoot, the surgeon removed the lead from the extension and contact 0 came off the lead and was inside the extension.Both the lead and extension were replaced.No symptoms were reported.No further complications were reported/anticipated.Additional information was received stating the lead/extension were never connected to the ins.The devices were sent back for analysis.
Additional Manufacturer Narrative
Analysis of the extension, s/n: (b)(4), revealed the distal end of the connector was twisted in molded rubber.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the extension (b)(4) found connector block #3 got twisted in the molded rubber.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 9795250
• Report Number: 2649622-2020-04613
• Device Sequence Number: 2611387
• Product Code: MHY
• UDI-Device Identifier: 00643169449152
• UDI-Public: 00643169449152
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2024
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 05/13/2020; 05/13/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 05/13/2020; 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR